AEROSPACE QUALITY MANAGEMENT SYSTEM STANDARDS - AS 9100 SERIES

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HISTORY OF 9100

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Background - Early to mid-1990s

Quality Assurance Management
ISO 9001,2,3 1980s-end 90s

(Inspect In Quality In Process)

Quality Assurance

(Manufacture In Quality)

(Inspect In Quality at end of line)

Quality Control

MIL-Q-9858 1960s-80s

MIL-I-45208 1940s-60s

Regulations (FAA, JAA, ESA, etc) Customers Specific Requirements

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Background - Early to mid-1990s

DOD (US Department of Defense) canceled quality system specifications (MIL-Q-9858) FAA (Federal Aviation Administration) lacks a definitive description of a quality system (FAR 21 & FAR145) Defense Customers and Aerospace Primes (mainly in Europe) began to flow ISO 9000 series plus unique requirements to suppliers Suppliers asked industry to standardize Needed to operate a single quality system Already adopting ISO 9000 series
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U.S. Industry Response - 1995

Supplier Management and Quality Assurance professionals from:

AlliedSignal Boeing GE Engines Lockheed Martin McDonnell Douglas

Pratt & Whitney Rockwell Collins Rolls-Royce Allison Sundstrand Northrop Grumman Sponsors

Aviation/Space & Defense Division of American Society for Quality SAE Aerospace Council
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Aerospace Industry Agree:

Where aerospace quality and safety is concerned... there is no competitive advantage

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Aerospace Standard birth

D1-9 000
DoD
Com pany Spec ific R eqm 1 N ts 00 M A 9 ISO FAA IL-Q SA

Inputs

AS9100
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IL

-I

Global Quality Standard Activity

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A Global Organization
International Aerospace Quality Group
IAQG Council General Assembly Forums

AAQG
(Americas)

EAQG
(Europe)

APAQG
(Asia)

Whose purpose is:

Implement initiatives that make significant improvements in Quality and reduction in cost, throughout the value stream, by establishing and maintaining dynamic cooperation, based on trust, between international aerospace companies S.Lichtenstein 28/1/2005 9

Global Approach to Improvement

Over 50 major aerospace companies across three global sectors Improvement through implementation of effective quality management systems and practices System and product integrity initiatives driven with constancy of purpose Co-operation, consultation and communication with: partners and suppliers airworthiness authorities customers across all sectors of business
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An Organization of Co-operation
Americas
The Boeing Company Bombardier CAE Embraer GE Aircraft Engines Goodrich Corporation Gulfstream Honeywell Aerospace Lockheed Martin Northrop Grumman Orbital Parker Aerospace Raytheon Rockwell Collins Rolls-Royce Corporation Textron United Technologies Corp. Vought PRI SAE

Europe
Airbus ALENIA BAE Systems Dassault Aviation EADS EADS CASA EADS Military Eurocopter (Fiat) Avio Fokker Aerostructures Westlands Hegan Hispano-Suiza Israel Aircraft Industries Messier-Bugatti Messier-Dowty MTU Aero engine Rolls-Royce SAAB Aerospace Smiths Industries SNECMA Moteurs Sonaca S.Lichtenstein Sukhoi

Europe Continued
Turbomeca
Volvo Aero Westland Helicopters Zodiac AECMA

Asia
Aerospace Industrial Development Corp. Aviation Industries of China Fuji Heavy Industries Ishikawajima Harima Heavy Industries Kawasaki Heavy Ind Korea Aerospace Ind Korean Air Aerospace Mitsubishi Heavy Ind Shin Mayawa Ind SJAC 28/1/2005 11

International Quality System Standard Creation 1998

Americas Standard

AS9000

ISO 9001 1994

World Aerospace Quality Standard ; AS/EN/JIS Q 9100

European Standard

prEN 9000-1

AS9100

ISO TC 20 WG11
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EN 9100
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Why 9100?

To standardize Aerospace quality expectations on a global level To achieve improvements in quality and reduce costs throughout the value stream ISO 9000 model for quality does not capture regulatory requirements or importance of safety, reliability or maintainability Captures aerospace supplements agreed to at an international level
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AEROSPACE SUPPLY CHAIN

9100
9110 for
Repair Stations
Tier 2 Integrators / Source Control/ Software Dev./ Major Assemblies Tier 3 - Integrators / Source Control / Specialty Electronics / Wiring / Compnts

Tier 1 Vehicle / Airframe / Propulsion Manufacture

Variation Reduction FAI Process Proving

9120

Tier 4 - Make to Print / Machine Shops / Processors Tier 5 - Distributors (Fasteners, Raw Materials, Commodities, Adhesives, Special Materials)

Tier 6 - Raw Materials (Castings, Forgings, Sheet, etc)

Sp

ia c e

s e s es c ro P l

Company Specific or NADCAP

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Aerospace Quality Standards Numbering System

International Standards - 91xx Harmonized across all 3 aerospace sectors and are recognized globally

AS Standards - Americas Published by Society of Automotive Engineers EN Standards - Europe published in Europe by ASD (former AECMA) JIS Q or SJAC is the Japan / Asia Equivalent
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Aerospace Quality System Standards

INTERNATIONAL STANDARDS

9100 - Quality System for Aerospace

Manufacturers

9101 - Check sheet for 9100 9110 - Quality System for Aerospace Repair
Stations

9111 - Check sheet for 9110 9120 - Quality System for Distributors 9121 - Check sheet for 9120
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Aerospace Quality System 9100 Standard versus ISO 9001

9100 added 83 additional and specific requirements to the 20 elements of ISO 9001
11 amplifications of ISO 9001 paragraphs are also inserted

Emphasis is placed on Design Control, Process Control, Purchasing, Inspection & Testing and Control of Non conformances
All areas that have the greatest impact on safety and reliability for aerospace products
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9001 implies 9100 requires)

ISO 9001: Generic quality management system standard - applicable to shoes as well as to airplanes

9100 Specifics (where ISO

9100:
Includes all ISO 9001 requirements Adds the expectations of the aerospace industry for a robust quality management system for aerospace products

Continuous Improvement:

Continuous improvement processes shall include provision for using the quality policy, quality objectives, audit results, measurement and analysis of data, variability reduction, corrective and preventive action, and management review (all but variability reduction are part of 9001:2000 requirements)
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ISO9001 versus 9100

9100 version is formatted to match ISO 9001:2000 and added requirements that provide for Regulatory organizations interfaces Configuration Management Design and Development V& V., & V&V testing Control of changes in Production Process Control of production equipment, tools, NC machines Control of work in outside facilities Control of service operations First Article Inspection Inspection documentation

These added requirements enables a standardized approach to supplier flow down requirements

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9100: Quality Management Systems (ISO Clause 4)

Requirements of regulatory authorities must be included in documentation

Including access by authorities to the records, documentation and change approval (as reqd)

Must show relationship of 9100 standard to lower level procedures Documented procedure for records control Requires Configuration Management for the product / process

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9100: Product Realization (ISO Clause 7)

Design and Development output includes:

Identification of Key Characteristics (FMECA) All necessary data to manufacture the product Gated Design Reviews Documentation of both Design Verification and Design Validation (reports / calculations / etc.) Design Verification and Validation testing

Design Change Control

Includes customer and regulatory approval as necessary
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9100: Product Realization (ISO Clause 7)

Purchasing

Responsible for all suppliers (incl. customer designated ones) Must have a list of suppliers Supplier performance review process Control of special process sources Whoever approves a supplier, can disapprove them as well Stringent flow down requirements - sub-tier Notification of nonconformance / process change Right of access by customer and regulatory personne
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9100: Product Realization (ISO Clause 7)

Planning for Production and Service:

Control plans and process controls In-process verification for hidden features Design of tooling for variable measurements

Controlled Production
accountability of product during manufacture evidence all operations are complete FOD control monitoring of environmental influences criteria for workmanship Use of approved data and specified tooling with S.Lichtenstein 28/1/2005 instructions

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9100 Special Process Requirements

7.5.2 Validation of processes for production and service

processes where the resulting output cannot be verified by subsequent monitoring or measurement. NOTE: These processes are frequently referred to as special processes. demonstrate the ability of these processes to achieve planned results. establish arrangements for these processes including, as applicable a) defined criteria for review and approval of the processes, qualification and approval of special processes prior to use, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, control of the significant operations and parameters of special processes in accordance with documented process specifications and changes thereto, d) requirements for records (see 4.2.4), and e) revalidation.
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Special Process Approval Objectives

To put in place industry controlled process for meeting requirements of 9100 clause 7.5.2 Supplier processes are an extension of the OEM processes To reduce redundant audits for the special process at suppliers and improve the global quality level Common requirements (auditors and audit questionnaires) Harmonized assessment process Data exchange Demonstrated industry managed process Process oversight Mutual system recognition
NADCAP/ASD PRO
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9100 Introduces Two important Concepts for Aerospace

First Article Inspections

Always required 9102 is mentioned for Guidance 9102 is only mandatory when specifically required in contracts

Key Characteristics
When specified 9103 is referenced for guidance 9103 is only mandatory when specifically required in contracts and key characteristics are identified
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9102 First Article Inspection

FAIs

apply:

to assemblies and all levels of parts within an assembly, including castings and forgings Suppliers responsible for ensuring that characteristics conform to Customer requirements Sub-tier suppliers and processors of parts and materials for suppliers
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What is Included in First Article Inspection?

Verification of All Design Characteristics:

Dimensional Verification via Marked-up (or Ballooned) Drawings that Correlate Characteristic Number from FAI to the Drawing. Part Marking Including Operator Certifications (e.g. NDT, Welding)

Material and Special Process Certifications Manufacturing Process Verifications

Manufacturing Routing Sheets. Referenced Exhibits Supporting the FAI (e.g. CMM Data Printouts, Test Data, Acceptance Test Procedures, Process Certifications, etc.). Process Capability Studies, As Applicable. Gauge Correlation, As Applicable. Tooling Traceability, If Tooling Is Used to Verify Design Characteristics
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Nonconformance Resolutions

9102 First Article Inspection

Any 9100 compliant organization in absence of a contractual requirement to use 9102 or other specific FAI customer requirement, can devise any methods and processes it chooses to meet the requirements of this clause and the "extent" of an FAI is also at the discretion of the organization as along as it is applied to each " new part" and subsequent changes thereto. New part means Parts, sub-assemblies and assemblies, however FAIs are progressive

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9103 Key Characteristics

Variation Management of Key Characteristics will provide a common standard for expectations for KCs within the aerospace industry. Key Characteristic (9100): The features of a material or part whose variation has a significant influence on the fit, performance, service life, or manufacturability. Dimensional features - thickness, diameter, length, etc. Chemical concentrations Time, Pressure, speed, rates, temperature, etc.
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Variation Management of Key Characteristics Purpose (9103)

Intent to drive the improvement of the manufacturing processes through adequate planning and effective management of Key Characteristic variation. Methodology for component/process proving focused on Key Characteristics. Understanding processes Using appropriate tools Demonstrating acceptable process capabilities Guidelines for reporting process capability data to primes.
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9100 Checklist - 9101

IAQG developed 9101 Common Checklist to be used by industry to cover all ISO 9001 & 9100 elements allows industry to share audit information Must be used by Certification Bodies when performing 9100 audits

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9110 Repair Station Quality System

EN 9110 developed and implemented in Europe for facilities that perform maintenance and repairs of aircraft and aircraft products and adopted by other sectors
Based on 9100 requirements and FAA / JAA JAR 145 requirements Corresponding 9111 checklist has also been developed and published
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9120 Distributor Quality System

EN 9120 developed and implemented in Europe for pass through stockists / distributors that handle parts and supplies that are used in aerospace products International harmonized standard is agreed Checklist 9121 is also available
Based on 9100, but only applies necessary system requirements.

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Industry Leaders are Listening

Agreed to improve the overall approach to quality Major Aerospace Companies have agreed upon Quality Management System approval approaches A key objective is to reduce the number of audits There are significant benefits to the Aerospace Industry Working to develop our International processes to incorporate the new approach

International approach is based on a single agreed standard, harmonization of system application and share information

Summary

A single 9100 Aerospace standard An agreed single International procedure of application Sector scheme procedures harmonised and complete Implementation planned aggressively during 2005 Establish a mechanism for data exchange International auditor training and qualifications Continue to communicate to all Team will co-ordinate implementation programs Monitor and maintain progress

QUESTIONS

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